Pharmacodynamics Study of Enoxalow Compared to Clexane in Healthy Subjects After Subcutaneous Single Dose

Pharmacodynamics Study of Enoxalow, Produced by Blau Farmacêutica S/A, Compared to Clexane, Produced by Sanofi-Aventis Farmacêutica Ltda, in Healthy Subjects After Subcutaneous Administration.

The hypothesis of this trial is that the test drug (Enoxalow® - T) pharmacodynamics parameters are similar to the comparator drug (Clexane® - C) in healthy subjects following administration of single subcutaneous dose. The objective of this randomized, crossover, clinical trial is to evaluate the pharmacodynamic profile of the test drug Enoxalow® - T produced by Blau Farmacêutica, compared to the comparator drug Clexane®, produced by Sanofi-Aventis, by determining pharmacodynamic activities (including anti FXa and anti-FIIa), as surrogate markers for their circulating concentrations of the drug.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Heparin, Low-Molecular-Weight

Detailed Description

In addition other pharmacodynamic tests such as Tissue Factor Pathway Inhibitor (TFPI) activity, as well as the ratio of anti-FXa and anti-FIIa activity will be compared as secondary objectives.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo
    • Valinhos, Sao Paulo, Brazil, 13276-245
      • LAL Clínica

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Agree to all the purposes of the study by signing and dating the Informed Consent;
• Male, aged between 18 and 55 years, clinically healthy;
• BMI between 18.5 and 30;

Exclusion Criteria:

• Participation in clinical trials in the 12 months preceding the trial;
• Presence of pulmonary, cardiovascular, neurological, endocrine, gastrointestinal, genitourinary or other systems diseases;
• Acute disease in the period of 07 days before the beginning of the practical phase (administration of the drug) of the study;
• Chronic administration of medications for hypertension, diabetes or any other disease that requires continuous use of any drug;
• Hemoglobin < 13 g/dL;
• Continuous use of oral anticoagulants, platelet inhibitors or anti-inflammatory drugs;
• Use of medications that interact with enoxaparin;
• History of gastrointestinal bleeding, deep vein thrombosis or pulmonary embolism that may interfere with the clinical outcome of the study;
• History of coagulopathy and bleeding diathesis;
• Presence of changes in physical examination suggestive of coagulation disorders (bruising, petechiae, or bruising);
• Changes in the skin or subcutaneous tissue of the place of drug administration(eg liposuction in the abdomen);
• Absolute platelet count below 100 x 109 / L;
• History of chronic bleeding;
• History of acute haemorrhage in the past 30 days;
• History of sensitivity to mammalian-derived biological products, albumin or any component of the formulation;
• History of allergy or Steven Johnson disease;
• Current or previous history (under 12 months) use of illicit drugs and tobacco;
• History of alcohol abuse, current or previous (within 12 months);
• At the discretion of the Principal Investigator of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Teste; Enoxalow (Heparin, Low-Molecular-Weight) - Blau Farmacêutica S/A.	Drug: Heparin, Low-Molecular-Weight; single subcutaneuous administration of 40 mg of the test drug and the comparator drug, according to randomization, in a crossover design, each administration separated by 6 days of washout.; Other Names: Clexane; Enoxalow
ACTIVE_COMPARATOR: Comparador; Clexane (Heparin, Low-Molecular-Weight)- Sanofi-Aventis	Drug: Heparin, Low-Molecular-Weight; single subcutaneuous administration of 40 mg of the test drug and the comparator drug, according to randomization, in a crossover design, each administration separated by 6 days of washout.; Other Names: Clexane; Enoxalow

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
anti-FXa	0, 0:30, 1, 1:30, 2, 2:30, 3, 3:30, 4, 4:30, 5, 6, 8, 10, 12, 16, 20 and 24h after drug administration
anti-FIIa activity	0, 0:30, 1, 1:30, 2, 2:30, 3, 3:30, 4, 4:30, 5, 6, 8, 10, 12, 16, 20 and 24 hours after drug administration

Secondary Outcome Measures

Outcome Measure	Time Frame
Tissue Factor Pathway Inhibitor (TFPI)	0, 0:30, 1, 1:30, 2, 2:30, 3, 3:30, 4, 4:30, 5, 6, 8, 10, 12, 16, 20 and 24 hours after drug administration
ratio of anti-FXa and anti-FIIa activity	0, 0:30, 1, 1:30, 2, 2:30, 3, 3:30, 4, 4:30, 5, 6, 8, 10, 12, 16, 20 and 24h after drug administration

Collaborators and Investigators

• Sponsor: Azidus Brasil
• Investigators: Principal Investigator: Alexandre Frederico, Azidus Brasil

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2013
• Primary Completion (ACTUAL): November 1, 2013
• Study Completion (ACTUAL): November 1, 2013

Study Registration Dates

• First Submitted: September 20, 2012
• First Submitted That Met QC Criteria: September 24, 2012
• First Posted (ESTIMATE): September 25, 2012

Study Record Updates

• Last Update Posted (ACTUAL): October 31, 2022
• Last Update Submitted That Met QC Criteria: October 27, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: subjects
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin; Heparin, Low-Molecular-Weight; Tinzaparin; Dalteparin
• Other Study ID Numbers: ENOBLA0512SC-I; Versão 01 datada de 15.05.2012 (OTHER: LAL Clinica)